MRI-Guided LITT for Treatment Metastatic Brain Tumors

This study is currently recruiting participants.
Verified June 2013 by The Methodist Hospital System
Sponsor:
Information provided by (Responsible Party):
Pamela New, MD, The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01736722
First received: November 19, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

The Methodist Hospital Neurological Institute is conducting a clinical trial for patients suffering from Metastatic brain tumors. The objective for this study is to evaluate the safety and feasibility of a MRI-guided laser thermal therapy during a real-time MRI guidance for the treatment of brain metastasis.

Patient will undergo laser therapy using the MRI scan to plan the treatment and ensure proper placement of the laser within the tumor. The tumor will then be heated by the laser and monitored by study physicians through the real-time MRI to see and control temperatures in the tissue. One in place, the thermal laser will then surgically remove the lesions. After the procedure, post treatment MR images will thenbe acquired for the determination of the effective treatment region.


Condition Intervention
Brain Tumor
Device: Visualase®

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of MRI-Guided Laser Induced Thermal Therapy (LITT) for Metastatic Brain Tumors

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • Safety and Feasibility [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Safety: To determine that the procedure can be safely tolerated without adverse events based on a 30, 90, 180 day procedure-related morbidity and mortality. Feasibility: To determine that the the rate of technical success or failure to complete the initial procedure with no associated major complications.


Secondary Outcome Measures:
  • Number of patients with survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    30, 90, and 180 day imaging evaluation of the laser induced lesion Correlation: examination of the extent to which Visulase predictions based on MRTI data match lesion dimensions from post-therapy MRI assessments. Estimates of durations, required facilities, required personnel, and costs for all aspects of the treatment procedure. Local control of lesions at 30, 90, 180 days as defined by volume of lesion increasing by no more than 25%.

    Accrual of patient survival post Visualase therapy.



Estimated Enrollment: 22
Study Start Date: January 2009
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRI-guided laser induced thermal therapy
The target tumor/lesion will undergo laser therapy using the MRI scan to plan the treatment and ensure proper placement of the laser within the tumor. An MRI (Magnetic Resonance Imaging) is a exam that creates pictures using magnetic rays instead of x-rays. The tumor(s) will then be heated by the laser in an attempt to eliminate their presence. The physician will be able to see and control the temperature of the laser.
Device: Visualase®
The target tumor/lesion will undergo laser therapy using the MRI scan to plan the treatment and ensure proper placement of the laser within the tumor. An MRI (Magnetic Resonance Imaging) is a exam that creates pictures using magnetic rays instead of x-rays. The tumor(s) will then be heated by the laser in an attempt to eliminate their presence. The physician will be able to see and control the temperature of the laser.

Detailed Description:

This is a study for evaluating the feasibility and safety of MR-guided laser thermal ablation of treatment-resistant brain tumors using the Visualase® Thermal Therapy System (Manufactured by BioTex, Inc., Houston, TX). The Visualase system is FDA cleared for soft tissue ablation in a number of surgical specialties including Neurosurgery (see appendix for documentation). Patients with intracranial brain tumors measuring 3 cm or smaller in largest diameter that have failed any conventional therapy (surgery, stereotactic radiosurgery and/or whole brain radiotherapy) are eligible.

The target tissue containing the tumor will undergo MRI-guided laser induced thermal therapy. MR imaging is used to define the treatment volume as well as plan and verify placement of the applicator. The extent of ablation is quantitatively monitored and displayed during delivery using real-time, MR temperature imaging. MR temperature imaging will also be used to monitor and control the temperature of adjacent tissues. Treatment will be automatically stopped if the MR temperature feedback system reports the temperature in the adjacent tissue has risen above a preset threshold. Treatment can be manually stopped by the neurosurgeon monitoring the treatment in real-time at any point during the procedure by simply turning off the power to the laser from the Visualase® system console. After laser delivery, MR images can be used to verify the extent of treatment and plan a therapy delivery if necessary.

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. High-grade gliomas, metastatic brain tumors, and other brain tumors refractory to conventional medical therapy.
  2. Patient or family able and willing to give informed consent.
  3. Subjects with metastatic cancer to the brain who have failed at least one conventional therapy (surgery, stereotactic radio- surgery, chemotherapy, and/or whole brain radiotherapy).
  4. Four or fewer previously treated or untreated lesion(s) in the brain.
  5. Tumor size ≤ 3.0 cm in largest diameter.
  6. MR imaging is not contraindicated for the patient.
  7. Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.
  8. Able and willing to attend all study visits.
  9. Karnofsky Performance Scale score >50.
  10. Patients age 19 and older.

Exclusion Criteria:

  1. Patients or family unwilling or unable to give written consent.
  2. Patients who cannot physically fit in, or are too heavy for, the MRI scanner.
  3. Patients with contra-indications to MRI imaging, such as, but not limited to, some pacemakers or defibrillators, non- compatible aneurysm clips, shrapnel, or other internal ferromagnetic objects.
  4. Known sensitivity to gadolinium-DTPA, or glomerular filtration rate not compatible with receiving gadolinium-DTPA.
  5. Based on Treatment Planning Imaging (MR and/or CT):

    • Lesions localized in the brain stem.
    • Lesions less than 5mm from primary branches of cerebral vessels, venous sinus, hypophysis or cranial nerves.
    • Presence of more than 4 brain tumors at the time of enrollment.
    • Medical issues which prohibit the patient from undergoing surgery (as determined by the treating surgeon, anesthesiologist, IMPAC clinic, referring physician).
    • Positive pregnancy test for women of child-bearing age.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736722

Contacts
Contact: Kimbra S. Harris, CCRP 713-441-3834 ksharris@tmhs.org
Contact: Pamela Z. New, M.D. 713-441-3800 pnew@tmhs.org

Locations
United States, Texas
Methodist Neurological Institute - Department of Neurosurgery Recruiting
Houston, Texas, United States, 77030
Contact: Kimbra S. Harris, CCRP    713-441-3834    ksharris@tmhs.org   
Contact: Pamela Z. New, M.D.    713-441-3800    pnew@tmhs.org   
Principal Investigator: Pamela Z. New, M.D.         
Sponsors and Collaborators
The Methodist Hospital System
Investigators
Principal Investigator: Pamela Z New, M.D. Methodist Neurological Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Pamela New, MD, Principal Investigator, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT01736722     History of Changes
Other Study ID Numbers: LITT
Study First Received: November 19, 2012
Last Updated: June 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The Methodist Hospital System:
Laser Induced Thermal Therapy
Metastatic cancer
Brain Tumor
Visualase
Treatment resistant
Magnetic Resonance Thermal Imaging
Magnetic Imaging

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 22, 2014